Extensive-stage Small-cell Lung CancerPhase 2NCT07654400
A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer
A Phase 2 study testing BL-M14D1 and Atezolizumab in people with Extensive-stage Small-cell Lung Cancer, run by Biokin (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- BL-M14D1 and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restriction;
- Age: ≥18 years;
- Expected survival time ≥3 months;
- Histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer that is incurable or for which there is currently no standard treatment;
- Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;
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- Must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
- Organ function levels must meet the required criteria;
- Urine protein ≤1+ or ≤1000 mg/24h;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment. Serum pregnancy testing must rule out pregnancy, and the patient must not be breastfeeding. All enrolled trial participants (regardless of gender) should take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.
Who cannot join
- Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;
- Previous treatment with ADC drugs using topoisomerase I inhibitors as toxins;
- Small cell carcinoma with non-small cell carcinoma components indicated by pathology must be excluded;
- Use of immunomodulatory drugs within 2 weeks before the first dose of the study;
- Receiving long-term systemic corticosteroid therapy at a dose >10 mg/day of prednisone or equivalent before the first dose;
- History of severe cardiovascular or cerebrovascular diseases;
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- Prolonged QTc interval, complete left bundle branch block, etc.;
- Active autoimmune diseases and inflammatory diseases;
- Diagnosis of another malignancy within 5 years before the first dose;
- Hypertension poorly controlled by two antihypertensive drugs;
- Patients with poorly controlled blood glucose;
- History of ILD/interstitial pneumonia treated with corticosteroids, etc.;
- Concomitant pulmonary diseases leading to clinically severe impairment of respiratory function;
- Presence of massive serous cavity effusion, or serous cavity effusion with symptoms, etc.;
- Imaging findings indicating that the tumor has invaded or encased major blood vessels in the chest, neck, pharynx, etc.;
- Any thrombotic event within 6 months before randomization;
- Patients with active central nervous system metastases;
- History of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or allergy to any excipient components of the investigational drug, etc.;
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Cumulative anthracycline dose >360 mg/m² during prior (neo)adjuvant anthracycline therapy;
- Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Active infections requiring systemic treatment, or occurrence of severe infection within 4 weeks before informed consent;
- Receipt of other unapproved clinical study drugs or treatments within 4 weeks before the first dose;
- Pregnant or breastfeeding women;
- History of severe neurological or psychiatric disorders;
- Presence of serious non-healing wounds, ulcers, or fractures within 4 weeks before signing informed consent;
- Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing informed consent;
- History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection, or presence of Crohn's disease, ulcerative colitis, or chronic diarrhea;
- Trial participants who plan to receive or have received live vaccines within 28 days before the first dose;
- Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Caicun Zhou
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M14D1 for Injection in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer
This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage small cell lung cancer.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- BL-M14D1, Atezolizumab
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-M14D1Drug
Administration by intravenous infusion for a cycle of 3 weeks.
AtezolizumabDrug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-M14D1+ Atezolizumab | Experimental | Participants receive BL-M14D1+ Atezolizumab for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-M14D1; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 12 months
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M14D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M14D1.
Measured: Up to approximately 12 months
Secondary outcomes (9)
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Measured: Up to approximately 12 months
Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).
Measured: Up to approximately 12 months
Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 12 months
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Measured: Up to approximately 12 months
Cmax
Maximum serum concentration (Cmax) of BL-M14D1 will be investigated.
Measured: Up to approximately 12 months
Tmax
Time to maximum serum concentration (Tmax) of BL-M14D1 will be investigated.
Measured: Up to approximately 12 months
Ctrough
Ctrough is defined as the lowest serum concentration of BL-M14D1 prior to the next dose will be administered.
Measured: Up to approximately 12 months
ADA (anti-drug antibody)
Frequency of anti-BL-M14D1 antibody (ADA) will be investigated.
Measured: Up to approximately 12 months
Drug-drug interaction (DDI)
Drug-drug interaction (DDI) refers to a situation in which the effects of one drug are altered by the presence of another drug.
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start9 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biokin (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654400
- Sponsor's protocol ID
- BL-M14D1-201
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M14D1 for Injection in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07654400
- Acronym / sponsor ID
- BL-M14D1-201
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Biokin (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II study is a clinical study exploring the efficacy and safety of BL-M14D1 in combination with Atezolizumab in patients with extensive-stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BL-M14D1+ Atezolizumab | Experimental | Drug: BL-M14D1, Drug: AtezolizumabParticipants receive BL-M14D1+ Atezolizumab for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restriction;
- Age: ≥18 years;
- Expected survival time ≥3 months;
- Histopathologically and/or cytologically confirmed extensive-stage small cell lung cancer that is incurable or for which there is currently no standard treatment;
Key exclusion criteria (30 listed)
- Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;
- Previous treatment with ADC drugs using topoisomerase I inhibitors as toxins;
- Small cell carcinoma with non-small cell carcinoma components indicated by pathology must be excluded;
- Use of immunomodulatory drugs within 2 weeks before the first dose of the study;
- Receiving long-term systemic corticosteroid therapy at a dose >10 mg/day of prednisone or equivalent before the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-M14D1Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-M14D1+ Atezolizumab |
| AtezolizumabAdministration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-M14D1+ Atezolizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 12 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to approximately 12 months
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M14D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M14D1.
9 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to approximately 12 months
Disease Control Rate (DCR)
Time frame: Up to approximately 12 months
Duration of Response (DOR)
Time frame: Up to approximately 12 months
Overall Survival (OS)
Time frame: Up to approximately 12 months
Cmax
Time frame: Up to approximately 12 months
Tmax
Time frame: Up to approximately 12 months
Ctrough
Time frame: Up to approximately 12 months
ADA (anti-drug antibody)
Time frame: Up to approximately 12 months
Drug-drug interaction (DDI)
Time frame: Up to approximately 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BL-M14D1 and Atezolizumab in people with Extensive-stage Small-cell Lung Cancer, run by Biokin (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.